MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD LONG NECK 48MM; HIP COMPONENT

Model Number	38AM4835
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See investigation attached.(b)(4).
Event or Problem Description
Allegedly, patient was revised due to acetabular component loosening , metallosis with probable adverse tissue reaction and elevated ions levels of his right hip.

• Brand Name: CONSERVE A-CLASS BFH HEAD LONG NECK 48MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10400953
• Report Number: 3010536692-2020-00568
• Device Sequence Number: 2975542
• Product Code: KWA
• UDI-Device Identifier: M68438AM48351
• UDI-Public: M68438AM48351
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 38AM4835
• Device Catalogue Number: 38AM4835
• Device Lot Number: 087447214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention